Catheter system for implantation of prosthetic heart valves

Patent metadata

Field	Value
Publication number	US-11517431-B2
Application number	US-201916665502-A
Country	US
Kind code	B2
Filing date	Oct 28, 2019
Priority date	Jan 20, 2005
Publication date	Dec 6, 2022
Grant date	Dec 6, 2022

Abstract

The invention relates to a catheter for the transvascular implantation of prosthetic heart valves, in particular including self-expanding anchorage supports (10), which allow a minimally invasive implantation of prosthetic heart valves. The aim of the invention is to reduce the risk to the patient during the implantation. To achieve this, according to the invention a prosthetic heart valve with anchorage supports is temporarily housed in a folded form in a cartridge-type unit (4) during the implantation. The cartridge-type unit can be fixed on the proximal end of a guide system (1), which includes a flexible region (9) that can be guided through the aorta. Actuating elements (2, 3) run through the interior of the hollow guide system, said elements permitting sections of the cartridge-type unit to be displaced radially about their longitudinal axis and/or laterally in a proximal direction, thus allowing individual sections of the anchorage support and the associated prosthetic heart valve to be sequentially released.

First claim

The invention claimed is:

1. A catheter system for implanting a prosthetic heart valve in a patient, the catheter system comprising:
a guide system;
a cartridge unit disposed at a distal end of the guide system, in mechanical and configured to retain the prosthetic heart valve in a collapsed state, the cartridge unit comprising a first sleeve, a second sleeve configured to move with respect to the first sleeve, and a third sleeve comprising at least one anchoring configured to engage the prosthetic heart valve, the third sleeve configured to be disposed within and move with respect to the first sleeve; and
a handle positioned at a proximal end of the guide system, the handle configured to be manipulated to cause sequential movement of the second sleeve and the third sleeve to sequentially transition the prosthetic heart valve from (i) the collapsed state to a partially expanded state and (ii) from the partially expanded state to a fully expanded state.

2. The catheter system of claim 1 , wherein movement of the second sleeve with respect to the first sleeve is configured to cause the prosthetic heart valve to transition to the partially expanded state.

3. The catheter system of claim 2 , wherein, after movement of the second sleeve with respect to the first sleeve, movement of the third sleeve with respect to the first sleeve is configured to cause the prosthetic heart valve to transition to the fully expanded state.

4. The catheter system of claim 1 , wherein the handle further comprises at least one manipulator.

5. The catheter system of claim 4 , wherein the at least one manipulator is a pushing handle.

6. The catheter system of claim 4 , wherein the at least one manipulator comprises a threaded engagement with the handle.

7. The catheter system of claim 1 , wherein the handle further comprises a first manipulator configured to cause the guide system to bend and a second manipulator configured to cause sequential movement of the second sleeve and the third sleeve.

8. The catheter system of claim 1 , wherein the at least one anchoring is configured to engage a first end of the prosthetic heart valve.

9. The catheter system of claim 1 , wherein the at least one anchoring is configured to engage at least one eye of the prosthetic heart valve.

10. The catheter system of claim 1 , wherein the guide system comprises a flexible region configured to be guided through an aorta of the patient.

11. A method for implanting a prosthetic heart valve, the method comprising:
delivering the prosthetic heart valve to an implantation site of a patient using a catheter system, the catheter system comprising a guide system, a handle positioned at a proximal end of the guide system, a cartridge unit disposed at a distal end of the guide system and adapted to retain the prosthetic heart valve in a collapsed state, the cartridge unit comprising a first sleeve, a second sleeve adapted to move with respect to the first sleeve, and a third sleeve comprising at least one anchoring adapted to engage the prosthetic heart valve, the third sleeve adapted to be disposed within and move with respect to the first sleeve; and
manipulating the handle to cause sequential movement of the second sleeve and the third sleeve to sequentially transition the prosthetic heart valve from (i) the collapsed state to a partially expanded state and (ii) from the partially expanded state to a fully expanded state.

12. The method of claim 11 , wherein manipulating the handle to cause sequential movement of the second sleeve and the third sleeve comprises causing the second sleeve to move with respect to the first sleeve to cause the prosthetic heart valve to transition to the partially expanded state.

13. The method of claim 12 , wherein manipulating the handle to cause sequential movement of the second sleeve and the third sleeve comprises causing the third sleeve to move with respect to the first sleeve to cause the prosthetic heart valve to transition to the fully expanded state.

14. The method of claim 11 , wherein the handle further comprises at least one manipulator.

15. The method of claim 14 , wherein the at least one manipulator is a pushing handle.

16. The method of claim 15 , wherein the pushing handle comprises a threaded engagement with the handle.

17. The method of claim 11 , wherein the handle further comprises a first manipulator adapted to cause the guide system to bend and a second manipulator adapted to cause the sequential movement of the second sleeve and the third sleeve.

18. The method of claim 11 , wherein the at least one anchor is adapted to engage a first end of the prosthetic heart valve.

19. The method of claim 11 , wherein the at least one anchor is adapted to engage at least one eye of the prosthetic heart valve.

20. The method of claim 11 , wherein the guide system comprises a flexible region, the method further comprising guiding the flexible region through an aorta of the patient.

Assignees

• Jenavalve Tech Inc

Inventors

• Ottma Rüdiger
• Moszner Robert
• Figulla Hans-Reiner
• Ferrari Markus
• Damm Christoph

Classifications

• A61F2/9517

  handle assemblies therefor · CPC title

• A61F2/2427 Primary

  Devices for manipulating or deploying heart valves during implantation · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61F2240/008

  Means for testing implantable prostheses · CPC title

• A61F2/2409 Primary

  Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442) · CPC title